Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 012097
Company: DELCOR ASSET CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KENALOG IN ORABASE TRIAMCINOLONE ACETONIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** PASTE;DENTAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/04/1960 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/22/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1993 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/13/1990 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/11/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1988 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/10/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/30/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/19/1986 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/23/1986 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/11/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/2002 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12907slr016LTR.pdf
06/16/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/22/1978 SUPPL-9 Labeling

Label is not available on this site.

05/09/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1977 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/08/1977 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2002 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English